Date: Sep 30, 1996 Author: Susan Lundine Source: bizjournals (
click here to go to the source)
Orlando's Autonomous Technologies Corp. received clearance Sept. 13 from the Food and Drug Administration to proceed with phase three clinical trials of its T-PRK technology -- a laser used in surgery to correct nearsightedness.
The trials, involving surgery on up to 500 patients, should begin later this year in up to seven sites in the United States, says Roslyn Palmiere, who handles investor relations for the company.
"Obviously, we are pleased with the FDA's clearance" and hope to finish the patients' surgeries by midyear 1997, says CEO Randy Frey.
The surgery would be followed by post-operative exams and follow-up to determine the accuracy, stability and safety of the surgeries.
The firm did its phase two trials on 180 patients in Greece and New Orleans. Of all the patients, 77 percent achieved 20/20 vision, and the rest achieved 20/40 vision or better. Eighty-three percent of the New Orleans patients, who had their surgeries done the most recently, reached 20/20 vision by three months, the company reports.
"As we progressed through the trial, our results got better, so the most recent patients had that terrific outcome," Palmiere says.
